DIN EN ISO 11239-2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on.pdf

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1、March 2013Translation by DIN-Sprachendienst.English price group 17No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 3

2、5.240.80!$N“1959443www.din.deDDIN EN ISO 11239Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchangeof regulated information on pharmaceutical dose forms, units ofpresentation, routes of administration and packaging (ISO 11239:

3、2012);English version EN ISO 11239:2012,English translation of DIN EN ISO 11239:2013-03Medizinische Informatik Identifikation von Arzneimitteln Struktur und kontrollierte Vokabularien zur Identifikation von pharmazeutischenDarreichungsformen, pharmazeutischen Konventionseinheiten, Anwendungsarten un

4、dVerpackungen (ISO 11239:2012);Englische Fassung EN ISO 11239:2012,Englische bersetzung von DIN EN ISO 11239:2013-03Informatique de sant Identification des mdicaments lments de donnes et structures pour lidentification unique et lchange dinformationsrglementes sur les formes des doses pharmaceutique

5、s, les units de prsentation, lesvoies dadministration et les emballages (ISO 11239:2012);Version anglaise EN ISO 11239:2012,Traduction anglaise de DIN EN ISO 11239:2013-03www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 35 pages02.13 DIN

6、 EN ISO 1239:2013-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11239:2012) has been prepared by Technical Committee ISO/TC 215 “Health infor-matics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” (Secretariat: NEN, Netherlands). The r

7、esponsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-07-03 AA Terminologie of Section 7 Medizinische Informatik. The DIN Standards corresponding to the International Standards referred to in this document are as fo

8、llows: ISO 3166 (all parts) DIN EN ISO 3166-1, DIN EN ISO 3166-2 and DIN ISO 3166-3 ISO 11238 DIN EN ISO 11238 ISO 11240 DIN EN ISO 11240 ISO 11615 DIN EN ISO 11615 ISO 11616 DIN EN ISO 11616 ISO 21090 DIN EN ISO 21090 National Annex NA (informative) Bibliography DIN EN ISO 3166-1, Codes for the rep

9、resentation of names of countries and their subdivisions Part 1: Country codes DIN EN ISO 3166-2, Codes for the representation of names of countries and their subdivisions Part 2: Country subdivision code DIN EN ISO 11615, Health informatics Identification of medicinal products Data elements and str

10、uctures for the unique identification and exchange of regulated medicinal product information DIN EN ISO 11616, Health informatics Identification of medicinal products Data elements and structures for unique identification and exchange of regulated pharmaceutical product information DIN EN ISO 11238

11、, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances DIN EN ISO 11240, Health informatics Identification of medicinal products Data elements and structures for unique identification an

12、d exchange of units of measurement DIN EN ISO 21090, Health Informatics Harmonized data types for information interchange DIN ISO 3166-3, Information and documentation Codes for the representation of names of countries and their subdivisions Part 3: Code for formerly used names of countries EUROPEAN

13、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11239 November 2012 ICS 35.240.80 English Version Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of prese

14、ntation, routes of administration and packaging (ISO 11239:2012) Informatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les formes des doses pharmaceutiques, les units de prsentation, les voies dadmini

15、stration et les emballages (ISO 11239:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation vonpharmazeutischen Darreichungsformen, pharmazeutischen Konventionseinheiten, Anwendungsarten und Verpackungen (ISO 11239:2012) This Eu

16、ropean Standard was approved by CEN on 24 May 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references con

17、cerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member i

18、nto its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,

19、 Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitatio

20、n in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11239:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Contents Page Foreword . 3 Introduction . 4 1 Scope . 6 2 Normative references. 6 3 Terms, def

21、initions and abbreviations 6 3.1 Terms and definitions 6 3.2 Abbreviations . 10 4 Requirements . 11 4.1 General requirements for controlled vocabularies . 11 4.2 Requirements for use within the IDMP set of standards . 12 5 Schema 12 5.1 General 12 5.2 Conceptual models Supporting concepts 13 5.3 Con

22、ceptual models High-level concepts 15 Annex A (informative) Examples of controlled vocabularies 22 Annex B (informative) Examples of controlled vocabularies to describe medicinal products . 28 Bibliography 33 2DIN EN ISO 11239:2013-03 EN ISO 11239:2012 (E) Foreword This document (EN ISO 11239:2012)

23、has been prepared by Technical Committee ISO/TC 215 Health informatics in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical tex

24、t or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by May 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for

25、identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

26、Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11239:201

27、2 has been approved by CEN as a EN ISO 11239:2012 without any modification. “”3DIN EN ISO 11239:2013-03 EN ISO 11239:2012 (E) IntroductionThis International Standard was developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. It is one of a g

28、roup of five standards which together provide the basis for the unique identification of medicinal products. The group of standards comprises:ISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medici

29、nal product information;ISO 11616, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information;ISO 11238, Health informatics Identification of medicinal products Data elements and stru

30、ctures for the unique identification and exchange of regulated information on substances;ISO 11239, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presenta

31、tion, routes of administration and packaging;ISO 11240, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement.These standards for the identification of medicinal products (IDMP) support the activities o

32、f medicines regulatory agencies worldwide by jurisdiction. These include a variety of regulatory activities related to development, registration and life cycle management of medicinal products, as well as pharmacovigilance and risk management.To meet the primary objectives of the regulation of medic

33、ines and pharmacovigilance it is necessary to exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support the following interactions (this is not an exhaustive list): regulator to regulator; pharmaceutical company to regulator; sponsor of clinical tri

34、al to regulator; regulator to other stakeholders; regulator to worldwide-maintained data sources.The necessary messaging specifications are included as an integral part of the IDMP standards to secure the interactions above.Unique identifiers produced in conformance with the IDMP standards are aimed

35、 at supporting applications where it is necessary to reliably identify and trace the use of medicinal products.There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and healthcare standards development domain for different purposes and in different contexts. The te

36、rms and definitions described in this International Standard are to be applied for the concepts which are required in order to uniquely identify, characterize and exchange regulated medicinal products and associated information.The terms and definitions adopted in this International Standard are int

37、ended to facilitate the interpretation and application of legal and regulatory requirements but they are without prejudice to any legally binding document. In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail.In the context of identificatio

38、n of pharmaceutical dose forms, units of presentation, routes of administration and packaging, this International Standard describes the essential elements for the specification, translation and versioning of the specified controlled terms. Also described are recommendations concerning the mapping o

39、f terms that are already used by stakeholders to the concepts arising from the implementation of this International Standard.4DIN EN ISO 11239:2013-03 EN ISO 11239:2012 (E) The high-level concepts defined consist of: pharmaceutical dose form; unit of presentation; route of administration; packaging.

40、The supporting, more mechanical, components are described separately from the high-level clinical concepts. The supporting concepts consist of: a) terms and codes; b) translations; c) versioning; d) mapping.5DIN EN ISO 11239:2013-03 EN ISO 11239:2012 (E) 1 ScopeThis International Standard specifies:

41、 the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devi

42、ces) related to medicinal products; a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; a mechanism for the versioning of the concepts in order to track their evolution; rules to allow regional authoriti

43、es to map existing regional terms to the terms created using this International Standard, in a harmonized and meaningful way.In addition, to support the successful application of this International Standard, references to standards concerned with identification of medicinal products (IDMP) and messa

44、ging for medicinal product information are provided as required.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document

45、 (including any amendments) applies.ISO 639 (all parts), Codes for the representation of names of languagesISO 3166 (all parts), Codes for the representation of names of countries and their subdivisionsISO 21090, Health informatics Harmonized data types for information interchange3 Terms, definition

46、s and abbreviations3.1 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1.1administrable dose formpharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured dose form has been carried outEXAMPL

47、ES Solution for injection, tablet for oral use, hard-capsule powder for inhalation.NOTE The administrable dose form is identical to the manufactured dose form in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical produ

48、ct).6DIN EN ISO 11239:2013-03 EN ISO 11239:2012 (E) 3.1.2administration deviceequipment intended for correct administration of the medicinal productEXAMPLES Needle, oral syringe.NOTE 1 An administration device may be an integral part of an immediate container or a closure.NOTE 2 Adapted from ENV 126

49、10:1997.3.1.3administration methodgeneral method by which a pharmaceutical product is intended to be administered to the patientEXAMPLES Application, inhalation, injection.NOTE The administration method is a general term that is used to group related pharmaceutical dose form concepts, and is not intended to describe a precise method or route of administration.3.1.4basic dose formgeneralised version